Objectives: Paclitaxel drug-eluting stents (DESs) have been shown to improve primary patency of femoropopliteal lesions compared to plain balloon angioplasty with provisional bare-metal stents (BMSs) in randomized controlled studies. However, data are lacking on patency outcomes of real-world DES use relative to BMS use. This study compared clinically driven target-lesion revascularization (TLR), target-vessel revascularization (TVR), and target-limb revascularization outcomes at 1 year between DES and BMS treatments in a real-world setting.
Methods: The study identified 174 DES (Zilver PTX; Cook Medical) and 784 BMS femoropopliteal interventions from the available 969 Excellence in Peripheral Artery Disease (XLPAD) registry patients between October 2013 and December 2016. We analyzed both unmatched (174 DES and 784 BMS) and propensity score (PS)-matched datasets (174 for each).
Results: This study found that patients who underwent DES femoropopliteal endovascular revascularization had significantly lower TLR rates in both unmatched (hazard ratio [HR], 0.57; 95% confidence interval [CI], 0.35-0.91; P=.02) and matched data (HR, 0.50 95% CI, 0.27-0.91; P=.02). The DES group had a 43% lower TVR risk than the BMS group in the PS matched cohort (HR, 0.57; 95% CI, 0.33-0.98; P=.04). Mortality rate in the DES group (5%) was significantly higher than the BMS group in both unmatched (2%; P=.04) and matched groups (1%; P=.046) at 1 year.
Conclusions: Patients treated with DES had higher lesion and vessel patency than BMS after adjusting for confounding, which included complexity of lesion characteristics and operators' clinical decision-making regarding selection of treatment modalities, in femoropopliteal endovascular interventions in a real-world registry.
Keywords: Zilver PTX; drug-eluting stent; endovascular revascularization; peripheral artery disease; propensity score matching; stent.